Biomarkers of Prednisolone Treatment (P05888)

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

Primary objective:

• To identify a biomarker or biomarker-set for the adverse metabolic effects of various doses of prednisolone treatment.

Secondary objectives:

• To describe the PK of prednisolone and PD of a series of biomarkers.

• To identify biomarkers that reflect side effects of prednisolone.

• To elucidate part of the mechanisms by which prednisolone induces metabolic changes.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 22 < BMI < 30

• fasting glucose < 5.6 mmol/L and glucose < 7.8 mmol/L 2hr after OGTT

• able and willing to sign informed consent

• history of good physical and mental health

• subject smokes less than 5 cigarettes per day

• able to keep a normal day and night rhythm

Exclusion Criteria:

• allergy to prednisolone

• glucocorticoid use during last 3 months prior to study

• use of any drug or substance

• history of familiar diabetes type 2

• clinically relevant history or presence of any medical disorder

• clinically relevant abnormal lab or ECG

• positive drug or alcohol screen, positive hepatitis B or C surface antigen

• donation of blood (>100 mL) within 90 days prior to the first dose